Trial Information

S-1 is a new chemotherapy drug. Some phase II trials showed S-1 is effective in HCC. S-1 combined with calcium folinate (SL) showed very good efficiency and safety in CRC. The short duration (two weekly regimen) is better than common course 4 week regimen in tolerance. So the investigators want to examine the efficiency and safety of SL one week on and one week off regimen in HCC.

SL one week on and one week off regimen will be give to advanced HCC patients. The primary endpoint is durable complete response (DCR).

Inclusion Criteria:

- Male or female, 70 years > Age > 18 years

- Patient with unresectable primary hepatocellular carcinoma

- Child-Pugh Class A or B, without ascites

- ECOG score 0

- At least one tumor nodule can be evaluated by CT or MRI

- Can take medicine orally

- Expected survival time not less than 12 weeks

- Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolling in this portion of the study During the trial and 4 week after the trial, must take contraception

- Patients must be:

- Hemoglobin > 9.0g/dl

- ANC > 1.5×109/L

- Platelet ≥ 60×109/L

- Total bilirubin < 3mg/dl

- ALT or AST < 5 X ULN

- ALP < 4 X ULN

- PT-INR < 2.3

- Patients who is taking Warfarin , should be tested every week till getting stable INR

- Serum creatinine < 1.5 X ULN

- Serum amylase and lipase < 2 X ULN

Exclusion Criteria:

- Known or suspected allergy to any agent given in association with this trial

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